MOSS(R) STEEL BREAKAWAY(R) INTRODUCER

Catheter, Suprapubic (and Accessories)

HARRY A. SCHLAKMAN

The following data is part of a premarket notification filed by Harry A. Schlakman with the FDA for Moss(r) Steel Breakaway(r) Introducer.

Pre-market Notification Details

Device IDK945480
510k NumberK945480
Device Name:MOSS(R) STEEL BREAKAWAY(R) INTRODUCER
ClassificationCatheter, Suprapubic (and Accessories)
Applicant HARRY A. SCHLAKMAN 301 VERONA AVE. Elizabeth,  NJ  07208
ContactHarry A Schlakman
CorrespondentHarry A Schlakman
HARRY A. SCHLAKMAN 301 VERONA AVE. Elizabeth,  NJ  07208
Product CodeKOB  
CFR Regulation Number876.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-08
Decision Date1995-08-28

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